labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Reported: March 14, 2018 Initiated: February 22, 2018 #D-0603-2018
Product Description
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Reason for Recall
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC.
- Units Affected
- 480 syringes
- Distribution
- GA, NE & PA
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028. Recalled by SCA Pharmaceuticals, LLC.. Units affected: 480 syringes.
Why was this product recalled? ▼
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Low. Recall number: D-0603-2018.
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